Empowering Support Persons to Enhance the Recovery Capital of Postpartum Women With Opioid Use Disorder - R61 Phase
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Recruitment Feasibility
研究概览
简要总结
We are studying whether training an identified support person and providing patient navigation (i.e. a peer recovery specialist assisting you with finding the right support) after delivery can increase "recovery capital"-the resources that help people with opioid use disorder (OUD) stay in treatment and recover. This study will build upon the research team's prior work in conducting research among pregnant and parenting women with OUD. This project will be directed by the research team at Friends Research Institute in close collaboration with their research and clinical partners at the University of Pennsylvania in Philadelphia, PA. A two-phase study is proposed with an initial 1-year developmental phase (R61) that will develop and pilot test STORC to include support person training. A second 4-year phase (R33) will test STORC in a parallel, two-arm, randomized controlled trial design at two study sites.
详细描述
The developmental R61 phase will focus on developing training materials and pilot testing STORC for feasibility and acceptability. This will be accomplished through three interrelated processes: 1) Developing materials to train support persons, including creating digital education content with expert consultants; 2) Pilot testing STORC recruitment procedures and training content to evaluate feasibility and acceptability; 3) Conducting qualitative interviews to gain diverse stakeholder input at the end of the pilot trial; and 4) Refining training materials into a final digital product with our media consultant.
Aim 1 (Months 2-12): We will develop and refine training materials to create a robust support person training. We will do this through an iterative process that first uses feedback from expert consultants with lived experience (two of whom are certified recovery specialists working in the PROUD clinic). These experts will develop scripts to communicate the training content to support persons, and we will work with our media production partner to produce the video content. After the pilot trial in Aim 2, we will refine the content and update any training portions that need improvement after qualitative interviews.
Aim 2: (Months 4-10) Pilot test STORC for feasibility and acceptability (N = 20 [10 patient/support person dyads]) and refine with feedback from the dyads at completion of the pilot. All participants will also view the training videos and provide feedback. The qualitative feedback and results of the pilot testing will inform the final STORC protocol used in the R33 phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •must be biological females
- •must be currently within 6 weeks postpartum
- •must be able to read, write, and speak English at a 6th-grade level
- •must be diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder at the PROUD clinic
- •must identify a support person who also consents to participate. Patient participants must identify prospective support persons in order to complete consent
排除标准
- •pregnancy
- •planned discharge to a long-term inpatient care facility (e.g., hospice)
- •hospitalization for a suicide attempt
- •major mental health disorder that requires treatment before OAT can be considered
- •stillbirth or neonatal death of the index pregnancy/infant, as determined from the obstetric record.
结局指标
主要结局
Recruitment Feasibility
时间窗: at study completion, up to 3 months
Number of eligible participants recruited for the trial relative to the number screened.
Acceptability of the Intervention
时间窗: At 3 month follow-up
Intervention acceptability will be measured using the 4-item Acceptability of Intervention Measure (AIM), a valid and reliable self-report measure of the extent to which participant accepts the intervention as relevant to their experience. The AIM is scored from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.
次要结局
- Appropriateness of the Intervention(at 3 month follow-up)
- Recovery Capital(Changes from baseline to 3 months follow-up)
- Self-efficacy(Changes from baseline to 3 months)
- Substance use(The past 30 days)